Government watchdog groups are sounding the alarm after an investigation into the approval of popular birth control pills, Yaz and Yasmin, revealed four Food and Drug Administration (FDA) advisors had strong ties to the drug’s manufacturer, Bayer Pharmaceuticals.
Yaz and Yasmin came under FDA review after a series of seven studies reviewing the serious side effects of Yasmin and Yaz indicated the contraceptives, which contain the active ingredient drospirenone, are more likely to cause dangerous blood clots in their users. Bayer had conducted its own studies and found the risk to be comparable to other contraceptives on the market.
After review of the studies, the FDA advisory committee voted 15 to 11 to keep Yaz and Yasmin on the market, reasoning the benefits of the contraceptives outweighed their risks. Curiously, the committee did recommend the labels on the drug be changed to warn physicians of the higher risk.
The Project on Government Oversight (PGO) a watchdog group, has asked the FDA to revisit their decision after uncovering several potential conflicts of interest with members on the advisory panel. PGO took issue with four advisors in particular, who were either affiliated with Bayer at one time or had ties to similar contraceptive companies that manufactured generic versions of the drugs.
PGO took special exception with the FDA’s decision to place Paula Hillard, a Stanford School of Medicine Professor on the panel. Hillard’s ties to Bayer were especially strong, having served as a consultant for the company until 2010. Investigation of internal Bayer documents also revealed the drug manufacturer viewed as a strong ally. Company papers from 2003 singled Hillard out as an important advocate for the company.
Unfortunately, Hillard’s ties are not unique on FDA panels. The FDA has historically taken a rather loose view on conflicts of interest and advisors with ties like Hillard’s are not especially unusual.
Bayer has been under fire for some time after numerous harmful effects sparked lawsuits against the company for its deceptive marketing campaigns promoting Yaz/Yasmin. Despite the lawsuits cutting into Bayer’s estimated $1.6 billion marketshare, Yaz/Yasmin remain the company’s second-best selling franchise last year.
Source: www.stanforddaily.com, “Hillard’s FDA Vote Scrutinized” 26 January 2012, Marshall Watkins